Genmab and partner Pfizer have received full approval for the cervical cancer drug Tivdak in the US, according to an press release.

Tivdak was granted accelerated approval in the US in September 2021 as a single treatment for patients with cervical cancer based on a phase II study.

The final application, which was granted priority review status by the US Food and Drug Administration (FDA), was based on the results of a phase III study published in October last year.

Tivdak met both its primary and secondary endpoints. Among other results, the drug showed a 30% lower risk of death compared to chemotherapy.

”The full FDA approval of TIVDAK represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing TIVDAK as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments,” says Jan van de Winkel, CEO of Genmab.

Translated using DeepL with additional editing by Kristoffer Grønbæk